RestoratIon of Myocardial Function by PeRcutaneous cOronary interVEntion in Patients With Ischemic CardioMyoPathy

NCT ID: NCT06930092

Last Updated: 2025-06-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 158 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-01
• Study Completion Date: 2029-04-30

Brief Summary

To compare the effects of physiology- and imaging-guided PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricular systolic function in patients with ischemic cardiomyopathy and multivessel coronary artery disease.

Detailed Description

This study is a prospective, open-label, randomized, multicenter trial to test the safety and efficacy of physiology- and imaging-guided complete revascularization with PCI combined with optimal medical therapy (OMT) versus OMT alone on the recovery of left ventricle ejection fraction (LVEF) in patients with ischemic cardiomyopathy and multivessel coronary artery disease.

The primary hypothesis is that physiology- and imaging-guided complete revascularization with PCI combined with OMT will show greater improvements in LV systolic function at 6 months after randomization compared with OMT alone.

Patients with left ventricular ejection fraction (LVEF) less than 40% on echocardiography will undergo gadolinium-enhanced cardiac MRI to determine the underlying cause of cardiac dysfunction and assess the presence of viable myocardium. Among patients suspected of having ischemic cardiomyopathy, those who provide informed consent will be considered for enrollment. Eligible patients undergoing invasive coronary angiography and meeting inclusion and exclusion criteria will be randomly assigned to either: a group receiving physiology- and imaging-guided PCI in combination with optimal medical therapy, or a group receiving optimal medical therapy alone.

Improvement in LVEF will be evaluated using follow-up gadolinium-enhanced cardiac MRI at 6 months. Clinical outcomes will be assessed at 6 and 12 months, and long-term outcomes will be analyzed through 36-month follow-up.

Conditions

Ischemic Cardiomyopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Physiology-and imaging-guided PCI

The goal is to achieve functional complete revascularization of major coronary arteries and their branches with diameters ≥2.5 mm. For lesions with ≥50% diameter stenosis, fractional flow reserve (FFR) measurement is mandatory. However, for severely stenotic lesions (>90%), revascularization may proceed at the operator's discretion without FFR assessment. In addition, intravascular ultrasound (IVUS) should be utilized during revascularization procedures and serve as an additional criterion for decision-making.

All patients in the intervention group will receive optimal medical therapy identical to that provided to the optimal medical therapy group following PCI.

Group Type: EXPERIMENTAL

Physiology-and imaging-guided PCI

Intervention Type: PROCEDURE

The criteria for performing revascularization are as follows

1. Lesions with ≥50% diameter stenosis and FFR ≤ 0.80, or lesions with severe stenosis (>90%)

2. In vessels meeting the above criteria, IVUS findings consistent with either:

• Minimum lumen area (MLA) ≤ 3 mm²
• 3 mm² < MLA ≤ 4 mm² and plaque burden >70%

For all target vessels and lesions identified for intervention, optimal revascularization should be pursued. The criteria for optimal revascularization are as follows, and operators are encouraged to achieve them:

1. Post-PCI FFR > 0.86 in all treated vessels is recommended, with a minimum threshold of post-PCI FFR > 0.80 to achieve functional complete revascularization.

2. Post-PCI ΔFFR (defined as [FFR at stent distal edge] - [FFR at stent proximal edge]) < 0.05 is recommended.

3. On IVUS, achieving a minimum stent area (MSA) > 5.5 mm² and MSA/average reference lumen > 80% is recommended.

Optimal medical treatment

All study participants will receive guideline-directed medical therapy, including an angiotensin receptor-neprilysin inhibitor (ARNi) or an angiotensin-converting enzyme inhibitor (ACEi) or angiotensin receptor blocker (ARB), a beta-blocker (carvedilol or bisoprolol), an aldosterone antagonist, and an SGLT2 inhibitor (empagliflozin or dapagliflozin). Medications will be administered even at low doses, as tolerated based on the patient's clinical status. Antiplatelet agents and statins will be maintained throughout the study period, and ezetimibe or PCSK9 inhibitors may be added as needed.

In addition, appropriate treatment will be provided for major cardiovascular risk factors such as hypertension, diabetes, and hyperlipidemia. Coexisting arrhythmias will be managed according to their respective guidelines. In the case of atrial fibrillation, active rate and rhythm control strategies will be implemented.

Group Type: ACTIVE_COMPARATOR

Optimal medical treatment

Intervention Type: DRUG

All study participants will receive guideline-directed medical therapy. Even for patients assigned to the optimal medical therapy group, revascularization may be performed during follow-up if clinically indicated. If such a decision is made prior to the primary endpoint assessment, a gadolinium-enhanced cardiac MRI will be performed at the time of consideration to reassess myocardial viability.

Interventions

Physiology-and imaging-guided PCI

The criteria for performing revascularization are as follows

1. Lesions with ≥50% diameter stenosis and FFR ≤ 0.80, or lesions with severe stenosis (>90%)

2. In vessels meeting the above criteria, IVUS findings consistent with either:

• Minimum lumen area (MLA) ≤ 3 mm²
• 3 mm² < MLA ≤ 4 mm² and plaque burden >70%

For all target vessels and lesions identified for intervention, optimal revascularization should be pursued. The criteria for optimal revascularization are as follows, and operators are encouraged to achieve them:

1. Post-PCI FFR > 0.86 in all treated vessels is recommended, with a minimum threshold of post-PCI FFR > 0.80 to achieve functional complete revascularization.

2. Post-PCI ΔFFR (defined as [FFR at stent distal edge] - [FFR at stent proximal edge]) < 0.05 is recommended.

3. On IVUS, achieving a minimum stent area (MSA) > 5.5 mm² and MSA/average reference lumen > 80% is recommended.

Intervention Type: PROCEDURE

Optimal medical treatment

All study participants will receive guideline-directed medical therapy. Even for patients assigned to the optimal medical therapy group, revascularization may be performed during follow-up if clinically indicated. If such a decision is made prior to the primary endpoint assessment, a gadolinium-enhanced cardiac MRI will be performed at the time of consideration to reassess myocardial viability.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Subject must be ≥ 19 years
• Subject is able to verbally confirm understandings of risks, benefits and treatment alternatives of receiving invasive physiologic or imaging evaluation and PCI and he/she or his/her legally authorized representative provides written informed consent prior to any study related procedure.
• Subject with LV ejection fraction <40% from cardiac MRI
• Subject with multivessel disease in major epicardial coronary artery disease or their major branches (vessel size of 2.5 mm or more than 2.5mm) considering coronary revascularization

Exclusion Criteria

• Subjects with more than 50% transmural extent of infarction on GE-MRI in more than 25% of the dysfunctional myocardial segments
• Subject with suspicious of other cardiomyopathy (dilated cardiomyopathy, hypertrophic cardiomyopathy etc.)
• Subject with recent myocardial infarction within 4 weeks
• Subject with recent fatal arrhythmia (VT or VF) within 4 weeks
• Subject with hemodynamically unstable state
• Subject with complex coronary artery lesions, such as chronic total occlusions, in which complete revascularization is considered unfeasible
• Subject for whom coronary artery bypass surgery is prioritized over coronary artery intervention
• Subject with severe valvular heart disease requiring open heart surgery
• Subject with history of coronary artery bypass surgery or valve surgery
• Subject with expected life expectancy of less than 1 year
• Subject considered ineligible for this study based on the investigator's discretion

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Seoul National University Bundang Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Boramae Hospital

OTHER

Sponsor Role: collaborator

Seoul National University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Seoul National University Hospital

Seoul, Chongno-gu, South Korea

Site Status: RECRUITING

Countries

South Korea

Central Contacts

Doyeon Hwang, MD

Role: CONTACT

cardiol.intv@gmail.com

82-10-7446-2779

Junpil Yun, MD

Role: CONTACT

junpilyun@gmail.com

82-10-8001-9969

Facility Contacts

Doyeon Hwang, MD

Role: primary

cardiol.intv@gmail.com

01074462779

Junpil Yun, MD

Role: backup

junpilyun@gmail.com

82-10-8001-9969

Other Identifiers

Not yet assigned

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Not yet assigned

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

H-2411-106-1590

Identifier Type: -

Identifier Source: org_study_id